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Exporting from Brazil — CFG (Free Sale Certificate)

BR-unique

Brazilian manufacturers and importers wishing to export medical devices to other countries often need a Certificado de Exportação (CFG — Certificate to Foreign Government), also commonly referred to as a Free Sale Certificate (FSC).

What the CFG certifies​

The CFG is issued by ANVISA and certifies that:

  • The named medical device is registered/notified/cadastred with ANVISA;
  • The device is legally manufactured and/or sold in Brazil;
  • The manufacturer or importer holds a valid AFE; and
  • The device has not been subject to market withdrawal or cancellation of registration.

Who issues the CFG?​

ANVISA issues CFGs via the Peticionamento Eletrônico portal. The application can be submitted by the registration holder (manufacturer or importer).

When a CFG is required​

Importing countries that require a CFG include:

  • Most MERCOSUL countries (Argentina — ANMAT, Uruguay — MSP, Paraguay);
  • Many African and Middle Eastern markets;
  • Several Asian markets (though requirements vary widely);
  • Some Latin American markets outside MERCOSUL (Colombia, Peru, Chile, etc.).

The EU, US, Australia, and Health Canada do not typically require a CFG as a mandatory submission document, but it is accepted as supporting documentation.

Applying for a CFG​

  1. Log in to Peticionamento Eletrônico.
  2. Select "Certificado de Exportação — Produto para Saúde."
  3. Provide the ANVISA registration number and device details.
  4. Pay the applicable fee.
  5. ANVISA issues the CFG (typically within a few weeks).
Official sources

Verify all information against official ANVISA sources before making regulatory decisions.